Division of Joint Reconstruction, Department of Orthopedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan.
Department of Surgery, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Stem Cell Res Ther. 2021 Oct 30;12(1):562. doi: 10.1186/s13287-021-02631-z.
To evaluate the safety and efficacy of intra-articular (IA) injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE® for knee osteoarthritis.
This was a patient-blind, randomized, active-control trial consisted of 4 arms including hyaluronic acid (HA) control and 3 ELIXCYTE® doses. A total of 64 subjects were screened, and 57 subjects were randomized. The primary endpoints included the changes from baseline to post-treatment visit of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 24 and the incidence of adverse events (AEs) and serious adverse events (SAEs).
No ELIXCYTE®-related serious adverse events were reported during 96 weeks of follow-up and no suspected unexpected serious adverse reaction (SUSAR) or death was reported. The changes of the primary endpoint, WOMAC pain score at Week 24, showed significant differences in all ELIXCYTE® groups, as well as in HA groups between post-treatment visit and baseline. The ELIXCYTE® groups revealed significant decreases at Week 4 compared to HA group in WOMAC total scores, stiffness scores, functional limitation scores suggested the potential of ELIXCYTE® in earlier onset compared to those from HA. The significant differences of visual analog scale (VAS) pain score and Knee Society Clinical Rating System (KSCRS) functional activities score at Week 48 after ELIXCYTE® administration suggested the potential of ELIXCYTE® in the longer duration of the effectiveness compared to HA group.
ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group.
ClinicalTrials.gov Identifier: NCT02784964. Registered 16 May, 2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02784964.
评估关节内注射同种异体脂肪来源干细胞（ADSCs）ELIXCYTE®治疗膝骨关节炎的安全性和有效性。
这是一项患者盲法、随机、活性对照试验，包括透明质酸（HA）对照和 3 种 ELIXCYTE®剂量共 4 个组。共筛选了 64 例患者，57 例患者被随机分组。主要终点包括治疗后 24 周时 Western Ontario 和 McMaster 大学骨关节炎指数（WOMAC）疼痛评分与基线相比的变化，以及不良事件（AE）和严重不良事件（SAE）的发生率。
在 96 周的随访期间，未报告与 ELIXCYTE®相关的严重不良事件，也未报告可疑意外严重不良反应（SUSAR）或死亡。主要终点（WOMAC 疼痛评分）在所有 ELIXCYTE®组以及 HA 组中，在治疗后访视与基线相比均有显著变化。与 HA 组相比，ELIXCYTE®组在治疗后第 4 周时 WOMAC 总评分、僵硬评分和功能限制评分的变化有显著下降，表明 ELIXCYTE®在起效时间上具有潜在优势。在 ELIXCYTE®治疗后第 48 周时，视觉模拟量表（VAS）疼痛评分和膝关节协会临床评分系统（KSCRS）功能活动评分的显著改善表明，ELIXCYTE®的疗效持续时间比 HA 组更长。
ELIXCYTE®治疗膝骨关节炎有效、安全、耐受良好。疗效结果表明，ELIXCYTE®在降低疼痛评分和改善功能评分方面比 HA 组更早起效。
ClinicalTrials.gov 标识符：NCT02784964。2016 年 5 月 16 日注册-回顾性注册，https://clinicaltrials.gov/ct2/show/NCT02784964。
